Z-0428-2013 Class II Terminated
FDA device recall Z-0428-2013 was initiated by Innovative Magnetic Resonance Imaging Systems Inc. on October 19, 2012 and is designated Class II. Reason for recall: IMRIS Inc. initiated a recall of their OR Tables ORT100 and ORT200. When proper procedure is not followed, the foot end of the IMRIS intra-operative OR table may be attracted to the MRI magnet as the … The recall status is terminated (terminated December 11, 2012). Affected quantity: 23.
Recall Details
- Product Type
- Devices
- Report Date
- November 28, 2012
- Initiation Date
- October 19, 2012
- Termination Date
- December 11, 2012
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 23
Product Description
IMRIS ORT100 (Part Number 110470-000) and ORT200 (Part Number 112216-00), are tables used in both the Neuro II-SE and Neuro III-SV Magnetic Resonance Imaging Systems.
Reason for Recall
IMRIS Inc. initiated a recall of their OR Tables ORT100 and ORT200. When proper procedure is not followed, the foot end of the IMRIS intra-operative OR table may be attracted to the MRI magnet as the magnet approaches the table. This poses a potential risk of injury to both the patient and operators standing near the table.
Distribution Pattern
Nationwide Distribution, including the states of FL, GA, IN, MD,MA, MI, MN, MO, TN, UT, and VA.
Code Information
10002845, 10002341, 10003244, 10002794, 10003243, 10003629, 10003801, 10002654, 10002796, 10002795, 10002846, 10002847, 10003830, 10003064, 10005201,10003754, 10004513